To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year [ Time Frame: Baseline, 1 year ] [ Designated as safety issue: No ]

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years [ Time Frame: Baseline, 2 year ] [ Designated as safety issue: No ]

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

Diagnosis and main criteria for inclusion. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

Patients with idiopathic Parkinson's disease of less than 7 years characterized as Stage I-III by the Modified Hoehn and Yahr Scale and with a maximum of 6 months cumulative lifetime exposure to levodopa and/or dopamine agonist. Patients on current dopamine agonist therapy would require 14-day washout.

Age at least 30 years.

Women of childbearing potential must have a negative serum beta-HCG pregnancy test at the Screen (Baseline) visit and the patient must use adequate contraceptive methods.

Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.

Exclusion criteria

Main criteria for exclusion. The presence of any of the following would make a patient ineligible for enrollment into the study:

Previous history of allergic response or complications with any dopaminergic agonist drug

Atypical PD syndromes

History of stereotactic brain surgery

Positive hepatitis B (surface antigen) or hepatitis C (antibody)

Surgery within 180 days of randomization which would negatively impact participation

Malignant melanoma or history of previously treated malignant melanoma.

Prohibited medications taken (including any drug known to have potential retino-toxic effects taken in the prior 12 months; neuroleptics taken within prior 6 months, MAO inhibitors except rasagiline or selegiline taken within prior 3 months, beta-blockers taken to treat Parkinson's disease in the prior 30 days, and Coenzyme Q10 taken within 14 days)

Albinism/Albinoidism of any degree, type or syndrome

History of glaucoma with or without treatment

Inherited or acquired retinopathy such as age-related macular degeneration with visual loss

Sarcoidosis

Diabetes mellitus of any degree even if diet or insulin controlled

Best corrected visual acuity (BCVA) of less than 20/40 by ETDRS

Refractive error of greater than minus-6 diopters

Abnormal electroretinogram (ERG)

Unable to dilate pupils

History of severe eye trauma that might affect the outcome of the study

History of psychosis

Participation in other investigational drug studies or use of investigational drugs within prior 30 days

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144300